Max 15872KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Max (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D76815872K0), received between Feb 11, 2021 and Jul 7, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 reports).
5 other recalls cover devices cleared under the same FDA submission (K051614); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate13
- Loss of Osseointegration4
Patient problems
- Osteopenia/ Osteoporosis9
- Inadequate Osseointegration8
- Unspecified Infection4
- High Blood Pressure/ Hypertension2
- Implant Pain2
- Osteolysis1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22420570 ↗InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 22, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19152730 ↗InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18498138 ↗InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18498023 ↗InjuryDec 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 18, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 18346613 ↗InjurySep 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Osteopenia/ Osteoporosis
MAUDE report 13505721 ↗InjuryFeb 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 12, 2021Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 11653984 ↗InjuryMar 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 11313298 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051614. One submission often covers many models, so check the product and lot details in each record.
- Z-2162-2018 · May 1, 2018 · TerminatedPrima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single
- Z-0608-2018 · Jun 20, 2017 · TerminatedMulti-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of
- Z-1818-2017 · Mar 9, 2017 · TerminatedKeystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
- Z-0299-2017 · Sep 15, 2016 · TerminatedKeystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles a
- Z-0973-2013 · Mar 11, 2013 · TerminatedPrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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